510(k) K850535— MITRATHANE DRESSING
Substantially Equivalent for Some IndicationsMitral Medical , Ltd.
Clearance details
- Applicant
- Mitral Medical , Ltd.
- Product code
- Code NAD
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Wheat Ridge, CO, US
Adverse events under product code NAD
product code NAD- Injury
- 431
- Malfunction
- 11,935
- Other
- 1
- Total
- 12,367
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.